Neurodevelopmental, Health, and Economic Outcomes at Preschool Age in Former Very Preterm Infants Randomized to An Economic Intervention to Support Mother's Own Milk - Project Summary Although most very preterm (born <32 weeks gestation) infants survive to discharge from the neonatal intensive care unit (NICU), they remain at an increased risk for impaired cognition and other neurodevelopmental impairments, obesity, chronic cardiometabolic conditions, and respiratory illnesses that burden families and translate into high healthcare and education costs over the lifespan. Existing observational studies in former very preterm children have suggested benefits associated with mother’s own milk (MOM) feedings due to its numerous bioactive components, but these studies are limited by the inability to ethically randomize very preterm infants to receive different doses of MOM. Our ongoing NIH-funded randomized controlled trial, “Reducing Disparity in the Receipt of Mother’s Own Milk in Very Low Birthweight Infants: An Economic Intervention” (ReDiMOM), tests the effectiveness of an economic intervention that mitigates the maternal costs of providing MOM in the NICU. ReDiMOM provides an economic bundle to intervention group mothers: free hospital grade electric breast pump rental, free pickup of pumped MOM from the home, and payment for each day spent pumping to offset maternal opportunity costs. Both intervention and control group mothers receive standard NICU-specific lactation care. This ethical randomization of an intervention to achieve higher NICU MOM doses provides the first opportunity to obtain experimental evidence of MOM’s long-term impact on health and economic outcomes into childhood. Through a second NIH-funded study examining toddler-age outcomes in children previously enrolled in ReDiMOM, we are collecting comprehensive, longitudinal data on MOM feedings, neurodevelopment, health, diet, adiposity, healthcare utilization, and economic outcomes at 2 years of age. Although we have been very successful in enrolling and retaining subjects in these studies, the far-reaching and costly complications of very preterm birth such as obesity, hypertension, and asthma, are rarely diagnosed during toddler age. Leveraging the randomized design of the ReDiMOM trial, the overall aim of this study is to continue the measurement of neurodevelopment, health, and economic outcomes in former very preterm infants through preschool age (ages 3-6 years). Aim 1 is to determine the effect of treatment group on outcomes at preschool age in former very preterm infants, including primary outcomes of cognition and societal cost, and secondary outcomes of behavior, motor, and executive function, health, and quality of life, and to evaluate the intervention’s cost-effectiveness. Aim 2 is to determine the association between total MOM feeding duration through two years of age and preschool age outcomes. This study will provide the highest quality of evidence for decision makers and essential economic data to enable prioritizing investment in effective strategies that support MOM for very preterm infants and reduce inequities in the receipt of MOM, ultimately leading to improved outcomes for all very preterm infants.
